510(k) · Cleared
ClearedUnitip High Resolution Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unisensor AG · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Mar 15, 2007 as substantially equivalent to K003580 (Unisensor AG, 2001) and 1 other predicate after a 225-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Mar 15, 2007
- Review
- 225 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011472 (2001). 3 ancestors in all, the oldest K003580 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011472 Polygram 98 Anorectal Function Testing Application, Polygram 98…Medtronic Functional Diagnostics A/S · 2001
- 1 generation backK031169 Motility Visualization SystemSierra Scientific Instruments, Inc. · 2003 · Recalled
- This deviceK062222 Unitip High Resolution CatheterUnisensor AG · 2007
- Descendant · cites it directly · 0 of its ownK190208 Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeDiversatek Healthcare · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK102801 Phtip Disposable Isfet CatheterE-Cath Co., Ltd. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal… | Medtronic Functional Diagnostics A/S | 2001 | — |
| −1 | K031169 | Motility Visualization System | Sierra Scientific Instruments, Inc. | 2003 | 1 |
| 0 (this device) | K062222 | Unitip High Resolution Catheter | Unisensor AG | 2007 | — |
| +1 | K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | Diversatek Healthcare | 2019 | 1 |
| +1 | K102801 | Phtip Disposable Isfet Catheter | E-Cath Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FFX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FFX device
- #1 K262621 Rapid Barostat Bag (RBB) Pump and Catheter…score 12.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003580 | Unitip Gastrointestinal Pressure Sensor CatheterSummary page 2…n also increases the maximum number of pH sensors to 7, and the maximum number of impedence rings to 14. Predicate Devices Unisensor AG, UniTip Pressure Sensor Catheter K003580 Sierra Scientific Instruments, Inc., Motility Visualization System K031169 Biocompatibility The requirements of the following st… | 2001 |
| * | K031169 | Motility Visualization SystemSummary page 2…ber of impedence rings to 14. Predicate Devices Unisensor AG, UniTip Pressure Sensor Catheter K003580 Sierra Scientific Instruments, Inc., Motility Visualization System K031169 Biocompatibility The requirements of the following standards have been used in part to establish substantial equivalence: EN 309… | 2003 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K190208 (Diversatek Healthcare, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K003580.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FFX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FFX
123in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFX
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFX
32in 2025
MAUDE reports naming product code FFX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 2 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 4 | 120 | 0 | 4 |
| 2013 | 1 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 3 | 145 | 0 | 15 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 1 | — | 0 | 17 |
| 2019 | 4 | 240 | 0 | 27 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 26 |
| 2022 | 0 | — | 0 | 31 |
| 2023 | 3 | 123 | 0 | 51 |
| 2024 | 1 | — | 0 | 59 |
| 2025 | 1 | — | 0 | 32 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The catheter probe is used to obtain a high resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract, and to allow storage of the corresponding data. The device is manufactured in the basic model variations listed below: 1. High Resolution Gastrointestinal Catheter with up to 40 pressure sensors: This model variation is intended for simple direct esophageal pressure, either at, above, or below the specific…
Read the full statement (244 words)
The catheter probe is used to obtain a high resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract, and to allow storage of the corresponding data.
The device is manufactured in the basic model variations listed below:
1. High Resolution Gastrointestinal Catheter with up to 40 pressure sensors:
This model variation is intended for simple direct esophageal pressure, either at,
above, or below the specific site of interest. Pressure information is provided at
multiple sensor sites. Pressures may be measured continuously, at rest, or
dynamically.
2. Gastrointestinal catheter, with pH sensors:
This model variation is the same as the High Resolution Gastrointestinal (GI)
catheter described above, except that this model variation includes up to 7 pH
sensors. PH probes are added to allow measurements of pH in the stomach and/or
esophagus.
3. Gastrointestinal catheter, with sleeve:
This model variation is the same as the High Resolution Gastrointestinal (GI)
catheter described above, except one or more of the pressure sensor sites will
include a sleeve. The sleeve is added to broaden the pressure sensitive zone for
the sensor site, and reduce positioning sensitivity.
4. Gastrointestinal catheter, with impedance rings:
This model variation is the same as the High Resolution Gastrointestinal (GI)
catheter described above, except it includes up to 14 conductive rings for
impedance studies.
5. Gastrointestinal catheter, with lumen
This model variation is the same as the High Resolution Gastrointestinal (GI)
catheter described above, except it includes a lumen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062222 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062222: Unitip High Resolution Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062222
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026